Ignite Creation Date:
2024-05-06 @ 1:07 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03933670
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2019-02-20
Brief Title:
Hyperpolarized Pyruvate 13C MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Phase 2 Study of Magnetic Resonance MR Imaging With Hyperpolarized Pyruvate 13C in Patients With Prostate Cancer on Active Surveillance
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies the side how well hyperpolarized carbon C 13 pyruvate HP C-13 pyruvate magnetic resonance imaging MRI works in monitoring patients with prostate cancer on active surveillance who have not received treatment Diagnostic procedures such as MRI may help visualize HP C-13 pyruvate uptake and breakdown in tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Optimize the imaging sequences that maximize signal-to-noise ratio SNR and intra-tumoral conversion of HP 13C pyruvate to lactate kPL and HP 13C pyruvate to glutamate kPG in regions of tumor versus vs adjacent benign tissue as assessed by multi-parametric MRI mpMRI imaging characteristics Part 1 II Determine the association between intra-tumoral kPL and kPG with Gleason grade determined during magnetic resonance MRultrasound US-guided fusion prostate biopsies obtained within 6 months following baseline HP C-13 pyruvate MR exam Part 2
SECONDARY OBJECTIVES
I Evaluate the intra-patient variability in intra-tumoral kPL and kPG with repeated dose studies
II Determine the association between peak intra-tumoral kPL observed on baseline imaging with serum prostate specific antigen PSA
III Compare and contrast intra-tumoral kPL and kPG with prostate imaging reporting and data system PI-RADS version 2 and individual mpMRI parameters including apparent diffusion coefficient ADC on diffusion-weighted imaging
IV Describe the frequency of up-grading of tumor with MRUS-guided fusion biopsy obtained following baseline HP C-13 MR exam
V Further characterize the safety profile of HP C-13 pyruvate injections
EXPLORATORY OBJECTIVES
I Correlate peak intra-tumoral kPL with results of gene expression profiling using DECIPHER assay
II Correlate peak intra-tumoral kPL and kPG with DECIPHER GRID tumor ribonucleic acid RNA expression of relevant components of the glycolytic pathway including lactate dehydrogenase LDH pyruvate dehydrogenase PDH aconitate hydratase aconitase myelocytomatosis oncogene MYC monocarboxylate transporter 4 MCT4 lactate transporter
III For patients who undergo optional follow-up HP C-13 pyruvateMRI 6-15 months following baseline scan determine the mean percent change from baseline in intra-tumoral kPL and kPG and whether the change from baseline is associated change in clinical risk assessment as determined by University of California San Francisco UCSF-Cancer of the Prostate Risk Assessment CAPRA risk score
OUTLINE
Patients receive hyperpolarized carbon C 13 pyruvate intravenously IV over less than one minute then undergo magnetic resonance spectroscopic imaging MRSI after 1-2 minutes Within 15-60 minutes patients may receive optional hyperpolarized carbon C 13 pyruvate and undergo MRSI Patients also undergo MRUS fusion-guided prostate biopsy within 12 weeks following HP C-13 MRSI
After completion of study patients will be followed up periodically
I Optimize the imaging sequences that maximize signal-to-noise ratio SNR and intra-tumoral conversion of HP 13C pyruvate to lactate kPL and HP 13C pyruvate to glutamate kPG in regions of tumor versus vs adjacent benign tissue as assessed by multi-parametric MRI mpMRI imaging characteristics Part 1 II Determine the association between intra-tumoral kPL and kPG with Gleason grade determined during magnetic resonance MRultrasound US-guided fusion prostate biopsies obtained within 6 months following baseline HP C-13 pyruvate MR exam Part 2
SECONDARY OBJECTIVES
I Evaluate the intra-patient variability in intra-tumoral kPL and kPG with repeated dose studies
II Determine the association between peak intra-tumoral kPL observed on baseline imaging with serum prostate specific antigen PSA
III Compare and contrast intra-tumoral kPL and kPG with prostate imaging reporting and data system PI-RADS version 2 and individual mpMRI parameters including apparent diffusion coefficient ADC on diffusion-weighted imaging
IV Describe the frequency of up-grading of tumor with MRUS-guided fusion biopsy obtained following baseline HP C-13 MR exam
V Further characterize the safety profile of HP C-13 pyruvate injections
EXPLORATORY OBJECTIVES
I Correlate peak intra-tumoral kPL with results of gene expression profiling using DECIPHER assay
II Correlate peak intra-tumoral kPL and kPG with DECIPHER GRID tumor ribonucleic acid RNA expression of relevant components of the glycolytic pathway including lactate dehydrogenase LDH pyruvate dehydrogenase PDH aconitate hydratase aconitase myelocytomatosis oncogene MYC monocarboxylate transporter 4 MCT4 lactate transporter
III For patients who undergo optional follow-up HP C-13 pyruvateMRI 6-15 months following baseline scan determine the mean percent change from baseline in intra-tumoral kPL and kPG and whether the change from baseline is associated change in clinical risk assessment as determined by University of California San Francisco UCSF-Cancer of the Prostate Risk Assessment CAPRA risk score
OUTLINE
Patients receive hyperpolarized carbon C 13 pyruvate intravenously IV over less than one minute then undergo magnetic resonance spectroscopic imaging MRSI after 1-2 minutes Within 15-60 minutes patients may receive optional hyperpolarized carbon C 13 pyruvate and undergo MRSI Patients also undergo MRUS fusion-guided prostate biopsy within 12 weeks following HP C-13 MRSI
After completion of study patients will be followed up periodically
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA232320-01A1 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchU01CA232320-01A1 |
| NCI-2018-02195 | REGISTRY | None | None |
| R01CA211150 | NIH | None | None |
| R01EB017449 | NIH | None | None |